Exact Sciences Announces Expanded Clinical Validation of the Oncodetect? Test and Molecular Residual Disease Innovation Roadmap

Exact Sciences Corp. announced new data to be presented from the Beta-CORRECT clinical validation study at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. Results from Beta-CORRECT, a subset of the GALAXY cohort, validate the performance of its tumor-informed molecular residual disease (MRD) test, Oncodetect?, in predicting recurrence in stage II-IV colorectal cancer.

These data confirm the test's role in supporting treatment and surveillance decisions. Building on this momentum and its commitment to innovation, Exact Sciences will introduce a next-generation version of the test leveraging the Broad Institute's MAESTRO technology. Early data show the test will track up 5,000 patient specific variants and detect ctDNA levels below 1 part per million.

The test will be available to both new and existing customers in 2026. The Beta-CORRECT study demonstrates that the Oncodetect test significantly improves prognosis prediction compared to traditional standard of care methods +,3,4,5 Data presented at ASCO from the Beta- CORRECT clinical validation study confirm that the On codetect test accurately predicts recurrence in stage III colorectal cancer3--consistent with findings from the Alpha-CORRECT study--and extends this association to stages II and IV. Exact Sciences' largest MRD clinical study to date, with more than 400 patients, demonstrates those with ctDNA-positive results after therapy and during surveillance showed a 24- and 37-fold increased risk of recurrence, respectively.

By quantifying ctDNA levels across multiple timepoints, the Oncodetect test enables physicians to more effectively guide treatment decisions and surveillance strategies in clinical practice. The next-generation MRD test, currently in validation across multiple solid tumor types, will track up to 5,000 patient-specific variants with a limit of detection below 1 part per million, enabling scalable monitoring and broad clinical utility. Exact Sciences holds exclusive rights to the Broad Institute's MAES TRO technology, a whole-genome sequencing method able to detect low-frequency ctDNA mutations with high accuracy.

This technology advances the ability to look broadly across thousands of mutations while reducing the sequencing depth required to achieve an ultra-low limit of detection at a highly attractive cost point. Through continued innovation in MRD, Exact Sciences is advancing solutions with the potential to change clinical practice.